From: Kim Smith [ksmith@nnfa.org]
Sent: Monday, September 08, 2003 6:20 PM
To: fdadockets@oc.fda.gov
Subject: CFSAN Program Priorities
National Nutritional Foods Association
3931 MacArthur Blvd. Ste. 101
Newport Beach, CA 92660
September 8, 2003
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
Re: Program Priorities in the Center for Food Safety and Applied Nutrition; Request for Comments [Docket No. 98N-0359], 68 FR 33727-01, Thursday, June 5, 2003.
Dear Sir/Madam:
NNFA is the oldest and largest, non-profit trade association dedicated to protecting and advancing the natural products industry. Our members include retailers, manufacturers and distributors of health food products, dietary supplements, and natural cosmetics. We submit the following recommendations regarding the establishment of FY 2004 program priorities in the Center for Food Safety and Applied Nutrition.
I. Make finalization of the proposed rule on current Good Manufacturing Practices for dietary supplements a top priority.
NNFA has long supported and encouraged the publication, adoption and implementation of cGMPs that are fair and appropriate for the industry. Now that the comment period for a proposed rule on dietary supplement cGMPs has closed, NNFA urges FDA to finalize cGMPs in a timely fashion provided they strike a more appropriate balance between an effective process control system and a testing scheme that confirms that the ingredients in the product meet specifications and that the process results in consistent quality products. NNFA has submitted comments to docket number 96N-0417 outlining a more appropriate testing regime and cGMP program.
II. Finalize rules on ephedrine-containing dietary supplements if this has not already been done in FY 2003.
NNFA strongly urges FDA to finalize a rule on ephedrine-containing dietary supplements. NNFA has submitted comments on this issue and does not object to the warning statement proposed March 5, 2003 by FDA in its reopening of the comment period for “Dietary Supplements Containing Ephedrine Alkaloids” published at 68 Fed. Reg. 10417. NNFA has long petitioned FDA to finalize a warning label for ephedrine containing dietary supplements and we are concerned about the possibility of this entire issue dragging into its eighth year.
III. FDA has the authority necessary to regulate dietary supplements, including adequate authority to pursue dangerous products.
FDA’s burden of proof to remove unsafe products has always been the same for food products, including dietary supplements. In 1994, the Dietary Supplement Health and Education Act (DSHEA) strengthened FDA’s hand by providing FDA with additional authority to address safety issues posed by dietary supplements. We outline some of FDA’s authority below:
a.. FDA has at its disposal the general food safety standard which allows the agency to take enforcement action against a dietary supplement if “it bears or contains any poison or deleterious substance which may render it injurious to health.” 21 U.S.C. §342(a)(1). DSHEA did not change the safety burden under this section.
b.. Additionally, under DSHEA, a dietary supplement is considered adulterated and subject to enforcement action where there is a “significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or under ordinary conditions of use.” 21 U.S.C. §342(f)(1)(A). Prior to DSHEA, FDA had to prove that a product posed a reasonable possibility of harm; “significant or unreasonable risk” is actually an easier safety burden for FDA to bear.
c.. In particularly compelling cases, DSHEA also allows the Secretary of the Department of Health and Human Services to immediately ban a dietary supplement if it is found to be an “imminent hazard.” 21 U.S.C. §342(f)(1)(C). No lawsuit is required as it is for other foods.
d.. Companies may not market new dietary ingredients unless a pre-market filing has been made to FDA. This allows the agency an opportunity to challenge the company’s determination that the product is reasonably expected to be safe. Admittedly, this is not the same as pre-market approval; however, the burden to stop the marketing of a new dietary ingredient under this section is not heavy. FDA must only show that a company has submitted “inadequate information” to show an ingredient does not pose a significant or unreasonable risk of illness or injury. 21 U.S.C. §350(b).
IV. NNFA urges FDA to continue enforcement initiatives against unsafe and misbranded dietary supplements.
On December 18, 2002, FDA announced the consumer Health Information for Better Nutrition Initiative in order to encourage the flow of high-quality, science-based information regarding the health benefits of foods, including dietary supplements, to consumers. As part of the initiative FDA committed itself to enforcing DSHEA and pledged to create strong disincentives for dietary supplement marketers to make false or misleading claims about a product.
NNFA is committed to supporting the development, marketing and use of only safe natural products. We strongly urge the Center to meet and uphold the goals identified in the Dietary Supplement Enforcement Report which accompanied materials explaining the initiative. FDA must continue to identify priority safety issues and initiate rigorous yet positive enforcement action against unsafe and misbranded dietary supplements. In so doing, we also urge FDA to publicize the procedures utilized to take such action and illustrate for the public and press the ability of FDA to regulate the industry under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
NNFA appreciates the opportunity to offer these suggestions concerning the establishment of program priorities for FY 2004. Please contact me in our DC office at (202) 223-0101 with any questions.
Respectfully submitted,
David Seckman
Executive Director/CEO